Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Inbios Intl., Inc. — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

136 daysmedian FDA review time
201 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
DEN100020DENV DETECT IGM CAPTURE ELISAInbios Intl., Inc.2011-04-081700
K041817WEST NILE DETECT IGM ELISAInbios Intl., Inc.2004-11-191360
K023483KALAZAR DETECTInbios Intl., Inc.2003-05-062010
K001092GENERIC BLOOD GLUCOSE TEST STRIPInbios Intl., Inc.2000-07-261130
K992695INSURE PRO TESTInbios Intl., Inc.1999-10-18680
K991515INSURE PREGNANCY TESTInbios Intl., Inc.1999-05-28280

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda